The FDA announced today that the recall of the Clearlink basic solution set with Duovent from Baxter (NYSE:BAX) is Class I, the most serious kind.
Clearkink with Duovent is part of a system for administering drugs and solutions to patients. Health providers use the majority of the sets to deliver hazardous drugs, such as chemotherapy drugs.
Reason for recall
Increased customer reports of leaks led Baxter to recall the Clearlink set, since the leaks could expose people to hazardous drugs.
Leaks may also allow air into the set or breach the sterile fluid pathway. These incidents increase the risk of air embolism and contaminated infusions, respectively. This could result in delayed or interrupted therapy, meaning patients may not receive the necessary amount of medication.
Altogether, these issues could lead to serious injury or death, an FDA notice said. To date, Baxter received 83 complaints with no reported injuries or deaths associated with the issues.
Baxter recalled the Clearlink basic solution set with Duovent. The product code is 2R8403 (all lots within expiry).
The company distributed 511,728 devices in the U.S. between Oct. 14, 2020, and June 30, 2022. Baxter initiated the recall on Aug. 9, 2022.
Instructions for users of recalled products
Baxter’s urgent medical device recall letter instructed users to monitor the use of impacted solution sets closely for leaks. They should stop the use of affected products if leaks are experienced. Affected products can be returned to Baxter.
The company is implementing corrective actions to resolve the issue. It plans to send a follow-up notification to customers with additional instructions.